Day 3 Embryo Biopsy Versus Blastocyst Biopsy in PGS Cases

NCT ID: NCT01950104

Last Updated: 2020-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-08-31

Brief Summary

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Preimplantation genetic diagnosis (PGS) is a technique that allow us to improve the results of assisted reproduction techniques through the selection of embryos free of chromosomal abnormalities.

At present, it has not been proved that the usage of PGS really improves the live birth rate in IVF cycles. However, it has been stated that the reason of not having better results when using PGS is that the methodology applied is not adequate.

Several authors propose that the optimal methodology for PGS includes the application of comparative genomic hybridization (CGH) arrays for genetic testing and carrying out embryo biopsy at the blastocyst stage. Nevertheless, most IVF centres still applies the day 3 embryo biopsy as a daily routine. Despite this fact, there is a gradual transition towards the usage of blastocyst-stage biopsy instead of day 3 biopsy.

The purpose of this clinical study is analysing the results of the IVF cycles with embryo biopsy for PGS. Live birth rates and other parameters as the pregnancy and implantation rates together with embryo quality will be analysed and compared between two groups of patients undergoing IVF cycles with PGS. In one group the biopsy will be applied in day 3 of the embryo development, while in the other group the embryo biopsy will be fulfilled at the blastocyst stage.

Detailed Description

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Conditions

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Infertility Embryo Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Day 3 embryo biopsy

Embryo biopsy is applied at day 3 of the embryo development

Group Type ACTIVE_COMPARATOR

Day 3 embryo biopsy

Intervention Type OTHER

Embryo biopsy is applied at day 3 of the embryo development.

Blastocyst biopsy

Embryo biopsy is applied at the blastocyst stage of the embryo development (day 5 or 6)

Group Type EXPERIMENTAL

Blastocyst biopsy

Intervention Type OTHER

Embryo biopsy is applied at the blastocyst stage of the embryo development

Interventions

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Day 3 embryo biopsy

Embryo biopsy is applied at day 3 of the embryo development.

Intervention Type OTHER

Blastocyst biopsy

Embryo biopsy is applied at the blastocyst stage of the embryo development

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients under 49 years undergoing IVF cycles with PGS for one of the following reasons:

* Advanced maternal age
* Recurrent implantation failure
* Recurrent abortion
* Severe male-factor infertility

Exclusion Criteria

* Not being able to sign the informed consent to participate in the study
* Patients undergoing preimplantation genetic diagnosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vida Recoletas Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IVI Sevilla

Seville, , Spain

Site Status

Countries

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Spain

Other Identifiers

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IVISEV-005VINCI

Identifier Type: -

Identifier Source: org_study_id

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